SUPPLY CHAIN ARTICLES
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![GettyImages-1269045566-rna]( "The Expanding Patent Landscape For RNA-Based Therapeutics")
The Expanding Patent Landscape For RNA-Based TherapeuticsThe COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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![Teamwok-GettyImages-1411776159]( "4 Risk Mitigation Strategies For mRNA Production")
4 Risk Mitigation Strategies For mRNA ProductionPlanning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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![Utility teamwork-GettyImages-2211320040]( "From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy")
From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA PolicyIn this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact.
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![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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![Leprechaun Man Dancing-GettyImages-538148163]( "ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)")
ARW's ATMP Manufacturing Must-Reads (ST. PATRICK'S DAY EDITION!)Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional roundup article.
SUPPLY CHAIN VIDEOS
Explore a state-of-the-art GMP facility focused on CRISPR based Cell and Gene therapies with helping temperature controlled warehouse and multiple synthesis suites.
There remain a lot of gaps in our understanding of plasmid quality, particularly for high-quality mRNA production (as opposed to viral vector production). In this segment of a recent Advancing RNA Live panel, speakers Adi Nair, Tyler Goodwin, and April Sena highlight their biggest questions around plasmid DNA quality, as well as the pros and cons of some of the analytical methods upon which we’re relying most heavily today to assess plasmid quality.
In this Advancing RNA Live clip, Khaled Yamout and Sanofi’s Francoise Ribes share the quality considerations that are top of mind when evaluating a novel raw material, as well as how the broader industry (i.e., standard setting organizations, suppliers, and biotechs) can arrive at a clearer understanding of a material’s quality.
When asked which specific topic they’d like to see discussed more regularly in the future as it relates to our supply chains, Featured speakers for the "Got Raw Materials? The State Of The mRNA Supply Chain" event were aligned around this one absolutely critical topic...
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-523692032]( "Moderna's Regulatory Journey: 3 Takeaways To Foster The mRNA Renaissance")
The story of how Moderna brought one of the first mRNA vaccines to the market has all the makings of a legend we will pass down through generations. However, unlike the legends of King Arthur or The Fountain of Youth, we can celebrate that Moderna’s legendary journey was — and still is — real. Not only did the mRNA vaccines help return life to normal, but they also kickstarted the mRNA therapeutic renaissance we’re happily experiencing today.
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![GettyImages-1357908552]( "Leveraging Single-Use Technology For mRNA-LNP Drug Manufacturing")
Single-use technology is vital for ensuring the quality and expedited market entry of genomic medicines. Learn how LNP technology is paving the way for a new era of personalized, precise medicine.
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![Gene Therapy iStock-1291142726]( "Key Challenges for CRISPR In Clinical Development")
Learn how to approach CRISPR cell and gene therapy development challenges, such as regulatory hurdles, ensuring consistency, finding qualified and experienced staff, and obtaining GMP-Grade reagents.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![Quality-GettyImages-1360733079]( "Understanding The Hidden Value Of Quality")
Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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![Thermo ABM pic]( "Delivering Global Media Manufacturing Consistency Through Site-To-Site Equivalency")
Explore a program focused on achieving process consistency through risk mitigation in four key areas: raw materials sourcing, equipment, manufacturing processes, and finished product testing.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
